Fix The Patent Laws

FTPL coalition members make submissions on Copyright Amendment Bill

Posted on | October 23, 2015 | No Comments

17 September 2015

The Copyright Amendment Bill 2015[1] was recently referred to parliament for review, following its approval by Cabinet. The Bill was drafted by the Department of Trade and Industry (DTI) to reform the Copyright Act 98 of 1978[2]. The Copyright Act governs the protection of copyright which – like patents – is a form of intellectual property.

The amendment of the Copyright Act is part of an ongoing process by the DTI to reform South Africa’s laws governing intellectual property. In 2013, the DTI released a draft National Intellectual Property Policy[3] (NIPP), which according to the DTI would establish a framework for reform.

The NIPP was welcomed by the Fix the Patent Laws campaign as it committed to pro-public health reform of South Africa’s intellectual property laws.[4] The Fix the Patent Laws campaign was launched in 2011 to advocate for full adoption of the flexibilities provided under the international Agreement on Trade Related Aspects of Intellectual Property[5] (“the TRIPS agreement”) to protect health into South Africa’s national laws.

The primary focus of this Fix the Patent Laws campaign has been to advocate for reform of South Africa’s Patent Act 57 of 1978 as the primary legislation that impacts on the cost of and access to medicines and medical technologies. While reform of the Patents Act is an urgent priority, it is essential that reform of all other Acts are coherent with pro-public health reform of the Patents Acts and guided by the need to fulfill constitutional obligations – including the realisation of the right to have access to health care services.

It was surprising to many stakeholders that the bill to amend the Copyright Act was released prior to the finalised NIPP to establish goals and objectives of reform. In addition to releasing the Copyright Bill, the DTI informed parliament on 17 March 2015 that bills to amend the following Acts related to the protection of intellectual property have already been drafted and are pending approval by the Minister of Trade and Industry Rob Davies: the Patents Act, Copyright Act, Counterfeit Goods Act, Trade Marks Act, Designs Act, Merchandise Act, Unauthorized Use of Emblems Act, and Performers’ Protection Act.[6]

16 September 2015 marked the close of the period for the public submissions on the Copyright Bill. FTPL coalition partners made submissions on the bill which are provided below. Key issues raised in FTPL partner’s submissions on the Bill are summarised below.

The objectives of reforms and the international and constitutional law context

Many Acts contain a Preamble that outlines the goals and objectives of the law (or bill to reform the law). While the Preamble of the bill to reform the Copyright Act listed proposed amendments, it did not shed light on the interpretation of the Act in light of the Constitution.

In their submissions, both Doctors Without Borders (MSF) and SECTION27 recommended including an additional purposes in the bill’s Preamble to outline the intention of the bill to “promote the spirit, purport and objects of the Bill of Rights” in terms of section 39(2) of the Constitution. The Bill of Rights enshrines the rights of all people living within South Africa – including the right to have access to health care services.

SECTION27 began by framing their submission in terms of the international and constitutional law context and provided analysis later, in respect of specific aspects of the Bill, to illustrate how to ensure that all law conforms to the Constitution.

The definition and practise of parallel importation as it relates to access to medicines and medical technologies

Parallel importation is a flexibility allowed under the international TRIPS agreement that countries may use to facilitate access to more affordable medicines and medical technologies. TRIPS explains that once a holder of an intellectual property protection (patent, copyright, trademark etc.) has placed its product on the market then its rights to protection have been exhausted and the product may be exported to another market without the consent of the intellectual property holder. The exporting of a product from one market where intellectual property rights have been exhausted to another market is known as “parallel importation”. Countries may use parallel importation to access more affordable versions of products that are marketed at lower prices in another market. Parallel importation is particularly important for countries seeking to access affordable medicines and medical technologies – as these products are often priced differently in different markets. In addition to using parallel importation to access more affordable versions of products with intellectual property protections, countries can also use this flexibility to import generic versions of medicines produced under compulsory and government use licenses.

The bill to amend the Copyright Act, provided a definition for parallel importation – as well as legislation regarding its practice. In their submissions, MSF and SECTION27 both noted their concerns regarding the definition of parallel importation in the Bill.

South Africa has never utilised parallel importation to access more affordable medical technologies, in part due to overly burdensome procedures outlined in regulations promulgated with respect to the Medicines Act 101 of 1965. Both SECTION27 and MSF noted that the definition of parallel importation in the Bill should be removed. MSF further recommended amendments to clauses related to practise of parallel importation in the bill, to facilitate its use in South Africa.

Avenues of legislative reform to address the implications of copyright protection for pharmaceutical package inserts

MSF and SECTION27’s submissions both discussed the implications of copyright protection for pharmaceutical package inserts. Section 15(1) the Medicines and Related Substances Act 1965 and the Regulation 9 of the General Regulations in terms of the Act require that all medicines are “accompanied by a package insert”.

In South Africa, originator companies have alleged copyright infringement of their package inserts by  generic medicine producers.[8] Therefore, copyright considerations have been used to undermine access to medicines.

Generic manufacturers must prove their products are interchangeable or therapeutically equivalent to the originator products in order to be registered for use.[9] A generic medicine “is a pharmaceutical product … intended to be interchangeable with an innovator [or originator] product”.11

It is unreasonable to expect producers of identical or bio-equivalent medicines to avoid copyright infringement of the originator product’s package insert text and design, when the products themselves must be the same, or substantially the same.

To avoid copyright infringement, many generic manufacturers in South Africa are currently forced to spend an inordinate amount of time and resources to develop unique package inserts.[10] This acts to delay companies’ registration of more affordable generic medicine, and could mean that the additional costs involved in avoiding copyright infringement are passed on to patients and the Department of Health.

Both SECTION27 and MSF submissions outlined several avenues of legislative reform to address the difficulties outlined above faced by producers of generic medicines.

SECTION27 provided four specific avenues of reform drawing on case law (abroad), international law and legislative precedent to substantiate recommendations. Specifically, the pressing need to remove the conflict between copyright considerations under the Copyright Act and the facilitation of access to safe, effective and quality medicines under the Medicines Act was highlighted.

The scope, purpose and procedures of the IP Tribunal

The bill establishes an Intellectual Property (IP) Tribunal to replace the Copyright Tribunal. The bill set out numerous types of matters which the IP Tribunal may adjudicate on. These matters went beyond copyright matters. The wide scope of the Tribunal highlight the shortcomings of embarking on legislative reform prior to the finalisation of the NIPP to establish a framework and objectives for reform. Both MSF and SECTION27 noted that the scope of the Tribunal is overly wide in the bill and must be limited to issues related to copyright as governed by the Copyright Act.

MSF called for amendments to the bill to ensure that proceedings of the Tribunal are transparent and operate in the interest of all people living in South Africa – and not just the commercial interests of copyright holders.

SECTION27 made specific recommendations on the IP Tribunal’s composition and its role in an overall dispute resolution framework for copyright matters.

Access to reading and learning material for people with disabilities

SECTION27’s submission, as well as a submission made by Marcus Low (Head of Policy of the Treatment Action Campaign) in his personal capacity dealt with access to reading and learning material for people with disabilities. Both submissions welcomed the proposed introduction of a copyright exception for disabled people. The exception allows for the making of accessible format books without first consulting the copyright holder and for the cross-border sharing of such accessible format books for the exclusive use of disabled people. Such a copyright exception would make it much easier for blind and otherwise disabled persons to access copyrighted materials in accessible formats – thereby increasing the access disabled persons have to education and to participation in the cultural life of society. These copyright exceptions pave the way for South Africa to ratify the 2013 Marrakesh Treaty to Facilitate Access to Published Works for Persons Who are Blind, Visually Impaired or Otherwise Print Disabled. SECTION27’s
submission also stressed though that the copyright exception in itself is only part of the solution and that there is an obligation on the state to take additional steps to ensure disabled people have access to printed works.

SUBMISSIONS AND RESOURCES: 

SECTION27, MSF and Marcus Low’s submission can be accessed at the links below:

These submissions included the joint submission of SECTION27, MSF and TAC on the NIPP as an annexure available below:

Additionally, below is a submission jointly made by SA and US academics on the Copyright Bill and annexured comments:

Finally, the Copyright Amendment Bill, Copyright Act and Draft National Policy on Intellectual Property (NIPP) are provided below:

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  • About the Campaign

    fix the patent laws
    Fix the Patent Laws is a campaign co-founded by SECTION27, Treatment Action Campaign (TAC) and Doctors Without Borders (MSF) in 2011. Since then, the coalition has grown to include 38 other organisations fighting together to push South Africa to amend its patent laws to prioritise public health. Through this blog we will highlight how amending South Africa’s Patents Act 57 of 1978 will reduce the cost of medicines, improving the health and saving the lives of millions of South Africans.

    The members of the Fix the Patent Laws Campaign are as follows: Treatment Action Campaign (TAC), Doctors Without Borders (MSF), SECTION27, the South African Non-Communicable Diseases Alliance (SANCD Alliance), DiabetesSA, EpilepsySA, Marie Stopes South Africa, Stop Stock Outs Project (SSP), South African Depression and Anxiety Group (SADAG), Cape Mental Health (CMH), the South African Federation of Mental Health (SAFMH), Schizophrenia and Bipolar Disorders Alliance (SABDA), as well as the following members of the Cancer Alliance and Advocates for Breast Cancer: Breast Course 4 Nurses, Breast Health Foundation, Cancer Association of South Africa (CANSA), Cancer Heroes, Can-Sir, CanSurvive, Care for Cancer Foundation, Childhood Cancer Foundation of South Africa (CHOC), Hospice Palliative Care Association (HPCA), Igazi Foundation, Look Good Feel Better, Love your Nuts, Lymphoedema Association of South Africa (LAOSA), Men’s Foundation, National Council Against Smoking, National Oncology Nursing Association of SA, Pancreatic Cancer Network of SA (PanCan), People Living With Cancer (PLWC), Pink Trees for Pauline, Pink Phoenix Cancer Foundation, Pocket Cancer Support, Project Flamingo, Rainbows and Smiles, Reach for Recovery, South African Oncology Social Work Forum (SAOSWF), The Pink Parasol Project, The Sunflower Fund, Vrede Foundation and Wings of Hope.

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